10502.1 The first registration of a device establishment shall be on Form FDA-2891 (Initial Registration of Device Establishment) or a similar form supplied by the Department. Subsequent annual registration shall be accomplished on Form FDA-2891a (Annual Registration of Device Establishment), furnished by the FDA, or a similar form furnished by the Department to establishments whose registration for that year was validated under § 10507.1. The forms shall be mailed to the owner or operators of all establishments via the official correspondent in accordance with the schedule as described in § 10501.1. The completed form shall be mailed no later than thirty (30) days after receipt from DOH.

10502.2 The initial listing of devices and subsequent June and December updates shall be on form FDA-2892 (Medical Device Listing) or similar form furnished by the Department. A separate form FDA-2892 or similar Department form shall be submitted for each device or device class listed with the Department. Devices having variations in physical characteristics such as size, packaging, shape, color, or composition should be considered to be one (1) device; provided, the variation does not change the function or intended use of the device.

10502.3 The listing obligations of the initial importer are satisfied as follows:

(a) The initial importer is not required to submit a form FDA-2892 or its Department equivalent for those devices for which such initial importer did not initiate or develop the specifications for the device or repackage or re-label the device. However, the initial importer shall submit, for each device, the name and address of the manufacturer. Initial importers shall also be prepared to submit, when the Department requests, the proprietary name, if any, and the common or usual name of each device for which they are the initial importers; and

(b) The initial importer shall update the information at the intervals specified in § 10505.

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013).